Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children

Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children

Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.

Therefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma [ɣ - IFN], interleukins [IL1-β, IL-4, IL-6, IL-8] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta [TGF - β]).

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Probiatop; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Ribeirão Preto, São Paulo, Brazil, 14048-900
      • Hospital das Clínicas FMRP-USP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Atopic Dermatitis
• Children over 6 months.
• Teens lower than 19 years

No inclusion / Exclusion Criteria:

• Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.
• Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.
• Allergy or severe adverse reactions attributable to the administration of the probiotic.
• Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.
• Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.
• Patient's request (or responsible's request)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiatop; Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months	Drug: Probiatop; Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.; Other Names: Probiotics
Placebo Comparator: Placebo; Placebo of Maltodextrin in sachet	Drug: Placebo; 1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.; Other Names: Maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SCORAD	Change from baseline in SCORAD every 3 months for 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin prick test (immediate awareness)		1 year
Inflammation composite	ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor	1 year
Immune tolerance composite	IL-10, TGF - β and IL -17	1 year
Total serum IgE		1 year

Collaborators and Investigators

• Sponsor: Casa Espirita Terra de Ismael
• Collaborators: University of Sao Paulo
• Investigators: Principal Investigator: Paula A Andrade, MD, HCFMRP-USP; Study Director: Persio Roxo-Junior, MD, PhD, HCFMRP-USP; Study Chair: Vanessa Carregaro, PhD, USP-RP; Study Chair: Jorgete Maria e Silva, MD, Msc, HCFMRP-USP; Study Chair: Luciana Roberti, FMRP-USP; Study Chair: Laís Sacramento, Msc, USP-RP

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 6, 2015
• First Posted (Estimate): August 11, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Probiotics; Awareness; Immune tolerance
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ProbioticsAD2015